Impurity profiling is the common name of a group of analytical activities, the aim of which is the detection, identification/structure elucidation and quantitat

Quality management (QM) practices are the basis for the successful implementation and maintenance of any QM system. Quality control (QC) is identified as a QM c

The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product lev

This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical

The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent an